Truvada, Foster City Drugmaker's HIV Prevention Pill, Draws Concern From Experts

Published: January 30, 2012

Foster City drugmaker Gilead recently updated its application with the federal Food and Drug Administration for approval to market its HIV treatment medication Truvada as a HIV prevention pill.

If the FDA approves Truvada for preventive use, it "would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV through sex," according to a company statement at the time of the filing last month.

Gilead’s application, however, has sparked debate among public health advocates who argue that the wide availability of the drug would discourage safe sex and would, in fact, increase the incidence of HIV.

"I believe that this could be catastrophic in terms of HIV prevention," said Michael Weinstein, president the AIDS Healthcare Foundation, based in Los Angeles. There are nearly 42,000 Californians [PDF] living with HIV as of June 2011.

Weinstein added that as an HIV treatment, he thinks Truvada is a "fabulous drug – it’s one pill once a day, and it has a low side-effect burden," which include nausea, vomiting and weight loss.

This new pharmaceutical prevention approach to HIV and AIDS is known in scientific circles as "pre-exposure prophylaxis," or PrEP, and it involves taking the antiretroviral medications on a daily basis. Clinical trials supported by the National Institutes of Health have shown that when taken daily, Truvada, a blue oval pill, reduced the risk for contracting HIV by between 44 percent among gay men in four countries and 73 percent by heterosexual couples in Uganda and Kenya. One trial among women in sub-Saharan Africa was stopped in April 2011.

Overall, these studies have generated enthusiasm among many medical researchers.

The drug is "an incredible achievement, a wonderful new tool that could be available to people who need additional protection against the acquisition of HIV," said Veronica Miller, executive director of The Forum for Collaborative HIV Research and a visiting professor at the UC Berkeley School of Public Health.

But Weinstein said he’s not yet convinced by the research, and he wouldn’t want to see future mass marketing of the drug discourage gay men – the risk group most seriously affected [PDF] by HIV, according to the Centers for Disease Control and Prevention – from using condoms based on "the false belief that they are protected by this," when there’s a possibility that those taking the medication still could contract the disease.

An article in the British medical journal The Lancet last year also argued that "although some of the trial results have been very impressive, the protection with pre-exposure prophylaxis is unlikely to be 100 percent, and making drugs available as prophylaxis could encourage high-risk sexual behaviour among those who believe themselves to be protected."

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